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| ID | Type | Description | Link |
|---|---|---|---|
| B5K-EW-IBHG | Other Identifier | Eli Lilly and Company |
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Slow enrollment
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The purpose of this two-part study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In Part A, each participant will receive two treatments, a single dose and a single dose with continuous infusion of U-500R insulin, both administered just under the skin. Participants who complete Part A will continue into Part B where they will be assigned to 1 of 2 treatments with U-500R insulin, injected either twice or three times daily under the skin for 5-10 days. This study can last from 7-14 weeks including initial screening and follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: U-500R Single Injection | Experimental | Bolus of U-500R administered via single subcutaneous (SC) injection. |
|
| Part A: U-500R CSII | Experimental | Bolus of U-500R administered via continuous subcutaneous insulin infusion (CSII). |
|
| Part B: U-500R TID | Experimental | U-500R administered thrice-daily (TID) via SC injection under steady state conditions for 5 to 10 days |
|
| Part B: U-500R BID | Experimental | U-500R administered twice-daily (BID) via SC injection under steady state conditions for 5 to 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U-500R | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R | Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R. | Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24 hours (h) post dose |
| Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R | Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC[0-24]) of U-500R. | Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
| Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R | Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R. | Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
| Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R | Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R. | Period 3 day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R | Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R. | Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research | Chula Vista | California | 91911 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of U-500 Insulin (Humulin LY041001) in Participants With Type 2 Diabetes | View source |
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Two parts study with Part A (Periods 1 & 2) & Part B (Period 3). Part A:Participants received study drug either by subcutaneous(SC) or continuous subcutaneous insulin infusion (CSII) as per the dosing sequence.
Part B: Participants received study drug via SC injection either twice daily (BID) or three times daily (TID) as per the dosing sequence.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants received 100- Unit (U) of human regular U-500 insulin (U-500R) by subcutaneous (SC) injection in period 1 and 4.25 U/hour U-500R basal infusion for 12 hours prior to and during the 24 hour clamp plus a 100-U of U-500R via continuous SC insulin infusion (CSII) in period 2 and U-500R administered thrice daily via SC injection in period 3. |
| FG001 | Sequence 2 | Participants received 4.25 U/hour U-500R basal infusion for 12 hours prior to and during the 24 hour clamp plus a 100-U of U-500R via continuous SC insulin infusion (CSII) in period 1 and 100-U of human regular U-500 insulin (U-500R) by subcutaneous (SC) injection in period 2 and U-500R administered twice daily via SC injection in period 3. |
| FG002 | Sequence 3 | Participants received 100-U of human regular U-500 insulin (U-500R) by subcutaneous (SC) injection in period 1 and 4.25 U/hour U-500R basal infusion for 12 hours prior to and during the 24 hour clamp plus a 100-U of U-500R via continuous SC insulin infusion (CSII) in period 2 and U-500R administered twice daily via SC injection in period 3. |
| FG003 | Sequence 4 | Participants received 4.25 U/hour U-500R basal infusion for 12 hours prior to and during the 24 hour clamp plus a 100-U of U-500R via continuous SC insulin infusion (CSII) in period 1 and 100-U of human regular U-500 insulin (U-500R) by subcutaneous (SC) injection in period 2 and U-500R administered thrice daily via SC injection in period 3. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Part A) |
| ||||||||||||||||
| Period 2 (Part A) |
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| Period 3 (Part B) |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants received 100-U of human regular U-500 insulin (U-500R) by subcutaneous (SC) injection or 4.25 U/hour U-500R basal infusion for 12 hours prior to and during the 24 hour clamp plus a 100-U of U-500R via continuous SC insulin infusion (CSII) in Part A (periods 1 & 2), and U-500R administered twice or thrice daily via SC injection in part B (period 3) as per the dosing sequence in each period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R | Part A: Pharmacokinetics (PK): Time to Maximum Drug Concentration (Tmax) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PK data in part A. | Posted | Median | Full Range | Hours (h) | Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24 hours (h) post dose |
|
Up to 72 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100-U Bolus U-500R SC | Participants received 100-U of human regular U-500 insulin (U-500R) by subcutaneous (SC) injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2016 | May 8, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2015 | May 8, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061386 | Insulin, Regular, Human |
| ID | Term |
|---|---|
| D007328 | Insulin |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 |
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| Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R | Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R. | Period 1 and 2: 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose |
| Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R | Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R. | Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
| Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R | Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R. | Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
| Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R | Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R. | Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Body mass index | Mean | Standard Deviation | Kilogram per square meter (kg/m^2) |
|
|
|
|
| Primary | Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to 24 Hours Postdose (AUC[0-24]) of U-500R | Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve from Zero to 24 Hours Postdose (AUC[0-24]) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PK data in part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomoles hour per liter (pmol*h/L) | Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
|
|
|
| Primary | Part B: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R | Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PK data in part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | Pico mole per liter (Pmol/L) | Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
|
|
|
| Primary | Part B: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R | Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PK data in part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | Milligram per Minute (mg/min) | Period 3 day 1: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18h post dose |
|
|
|
| Secondary | Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R | Part A: Pharmacokinetics: Area Under The Concentration Versus Time Curve From Time Zero to Last Time Point With A Measurable Concentration (AUC[0-tlast]) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PK data in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomole hours per liter (pmol^h/L) | Period 1 and 2: -0.5, 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose |
|
|
|
|
| Secondary | Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R | Part A: Pharmacodynamics (PD): Time to Rmax (tRmax) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PD data in Part A. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | Hour (h) | Period 1 and 2: 0, 0.5, 1, 2, 3, 4, 6, 7, 8, 12, 16, 24h post dose |
|
|
|
|
| Secondary | Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R | Part B: Pharmacokinetics: Time to Maximum Concentration (Tmax) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PK data in part B. | Posted | Median | Full Range | Hours | Period 3: -0.5, 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
|
|
|
| Secondary | Part B: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R | Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PK data in part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | Grams (g) | Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
|
|
|
| Secondary | Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R | Part B: Pharmacodynamics: Time to Rmax (tRmax) of U-500R. | All randomized participants who received at least one dose of study drug and had evaluable PD data in part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Period 3: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 11, 12, 13, 15, 18, 24h post dose |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 4 |
| 11 |
| EG001 | 100-U Bolus U-500R CSII | Participants received 4.25 U/hour U-500R basal infusion for 12 hours prior to and during the 24 hour clamp plus a 100-U of U-500R via continuous SC insulin infusion (CSII). | 0 | 11 | 0 | 11 | 3 | 11 |
| EG002 | U-500R BID | Participants received U-500R twice daily by SC injection for 5 to 10 days. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | U-500R TID | Participants received U-500R thrice daily by SC injection for 5 to 10 days. | 0 | 6 | 0 | 6 | 2 | 6 |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Medical device site swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Priapism | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Eye laser surgery | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
The only disclosure restriction on PI is that sponsor can review results communications and comment 30 days prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. If PI is unwilling to delay the results communication then PI can remove the information that sponsor has specified it reasonably believes would jeopardize its intellectual property interests.
| D004700 | Endocrine System Diseases |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |